Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05599906 |
| Other study ID # |
96/21 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 11, 2021 |
| Est. completion date |
August 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Paracelsus Harz Clinic Bad Suderode. |
| Contact |
Axel Schlitt |
| Phone |
+493948599784 |
| Email |
axel.schlitt[@]pkd.de |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of the present study is to answer the question of whether a rehabilitation measure
has a positive effect on fatigue symptoms, physical performance, and the physical and
psychological well-being of the patients. In particular, the fatigue that occurs in most of
all patients is of interest here. In order to make this measurable, the FAS questionnaire
plays a special role, which should be completed by all 100 patients upon inclusion in the
study and upon discharge from the rehabilitation clinic. In addition, the HADS-D
questionnaire (Hospital Anxiety and Depression Scale) for self-assessment of depressive
symptoms and anxiety symptoms and the SF-12 questionnaire (Short Form Health Survey) are used
as a screening tool to assess health-related quality of life.
For the clinical examination of physical performance, the six-minute walk test, a body
plethysmography and a long-term ECG are performed on recruited patients on admission and
before discharge. In a three-month follow-up, all recruited patients should receive an FAS,
HADS-D and SF-12 questionnaire to fill out. Some of these will also be called back to the
clinic to check the development of lung function or performance, defined on the basis of
VO2max, and will undergo an additional spiroergometric examination.
Thus, the effectiveness and effectiveness of the rehabilitation measures in patients under
long-COVID is checked.
Description:
The study is a prospective, monocentric cohort study in which patients with the main
diagnosis of long-COVID syndrome from the Paracelsus Harz Clinic, Bad Suderode, are included
and followed up over a period of three months.
The study population consists of patients from the rehabilitation clinic
Paracelsus-Harz-Klinik Bad Suderode. It is planned to enroll 100 patients, all of whom will
be included in a three-month follow-up. Within this follow-up, 20 of the 100 patients will be
selected to be re-examined in the clinic three months later. For this purpose, patients are
selected who live within a maximum distance of 50km from the Paracelsus Harz Clinic and who
are able to reach the clinic three months after completion of the rehabilitation measure.
After receiving the vote of the Ethics Committee of the Medical Association of the State of
Saxony-Anhalt (Bad Suderode) and the written consent of the patients, socio-demographic
information and questions are documented according to the standard of the rehabilitation
clinic. All relevant baseline parameters (age, gender, BMI, drug treatment, etc.) are also
documented. In order to obtain the essential values for the evaluation of the physical and
psychological condition of the patients, all patients receive an FAS questionnaire, a HADS-D
and an SF-12 questionnaire upon inclusion and at the end of the rehabilitation stay.
Furthermore, after admission and before discharge, a six-minute walk test, a lung function
test using body plethysmography and a long-term ECG for cardiological observation are carried
out.
After the patients have left the clinic, 80 of the recruited patients will be contacted by
post three months later in order to fill out the previously known questionnaires again. The
Fatigue Questionnaire (FAS Questionnaire) is of particular interest for checking the physical
and psychological development after completion of the rehabilitation treatment. In addition,
the patients should again receive the HADS-D and SF-12 questionnaires to check their mental
and physical well-being. If the patients cannot be reached, an attempt is made to obtain
follow-up information by telephone, relatives or general practitioners. The remaining 20
patients will be referred to the clinic again as part of the three-month follow-up so that
the development of lung function and performance, measured using VO2max, can be checked in
the form of spiroergometry. During their stay, they also receive the FAS questionnaire, the
HADS-D and the SF-12 questionnaire to fill out
